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Omega Alpha Pharmaceuticals FDA Inspection Record

FEI 3010129381 · Inspections, Form 483s, warning letters and import refusals

Omega Alpha Pharmaceuticals is an FDA-inspected facility (FEI 3010129381) located in Scarborough, CA. RegDataLab tracks 2 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Feb 24, 2022: Official Action Indicated (OAI)
Inspections on record
2 (2 OAI)
Last OAI inspection
Feb 24, 2022
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
10 or more

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Feb 24, 2022Official Action Indicated (OAI)Pest control measures (21 CFR 111.15(d)(2))
Master manufacturing record - each batch (21 CFR 111.205(a))
Component - verify identity, dietary ingredient (21 CFR 111.75(a)(1)(i))
Specifications met identity,purity, strength, comp,; basis (21 CFR 111.75(c)(3))
and 3 more
Feb 20, 2020Official Action Indicated (OAI)Batch record - every batch (21 CFR 111.255(a))
Batch record - date, time; maintenance (21 CFR 111.260(b))
Batch record - date, time; maintenance (21 CFR 111.260(c))
Batch record - yield (21 CFR 111.260(f))
and 14 more

FDA record score

28 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

9 records behind this number
RecordDatePoints x age weightAdds
Inspection classified OAIFeb 24, 202230 x 0.618
Inspection classified OAIFeb 20, 202030 x 0.257.5
13 import refusals in 2022Dec 31, 20222 x 0.61.2
18 import refusals in 2020Dec 31, 20202 x 0.250.5
11 import refusals in 2018Dec 31, 20182 x 0.250.5
68 import refusals in 2014Dec 31, 201410 years or older, so it adds no points0
16 import refusals in 2011Dec 31, 201110 years or older, so it adds no points0
11 import refusals in 2006Dec 31, 200610 years or older, so it adds no points0
39 import refusals in 2005Dec 31, 200510 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Omega Alpha Pharmaceuticals
Location
Scarborough (CA)
Source
inspections

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.